China NMPA Product Recall - X-ray computed tomography equipment, X-ray computed tomography equipment

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its X-ray Computed Tomography Equipment, as documented by the National Medical Products Administration (NMPA) with Index No. JGXX-2017-11189, published on December 7, 2017. The recall pertains to specific X-ray Computed Tomography Equipment models, including those registered under CFDA (Imported) No. 20163301984 and CFDA (Imported) No. 20123303860. The primary issue necessitating this action was identified as software problems affecting the functionality of the equipment. This proactive measure by Philips (China) aligns with regulatory requirements overseen by the NMPA. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. While no specific inspection dates are provided, the recall documentation suggests the issue was identified and acted upon around the time of the publication date in 2017. The company's required action is to remove the affected equipment from the market voluntarily. Comprehensive details, including models, specifications, and batch numbers of the recalled products, are contained within the "Medical Device Recall Event Report Form" attachment, ensuring transparency and aiding in the effective management of the recall process.